The present disclosure pertains to devices and methods for providing a protective sheath for lead wire cables intended for use in hospital or medical settings, particularly ECG/EKG Multi-Link leadwire sets.
Hospital-acquired infections caused by antibacterial-resistant microorganisms are associated with high mortality and morbidity rates and markedly affect hospital economics. According to the Association for Professionals in Infection Control, one out of every 20 hospitalized patients in the United States contracts a Hospital Acquired Infection. This equates to 1.7 million patients infected annually, accounting for 99,000 deaths. The cost of treating patients with hospital-acquired infections (“HAIs”) has increased markedly. Reports indicate that the cost of care of the 4% of patients with HAI wiped out 185% of the operating profits from all other patients. These numbers were generated before October 2008, when the Center for Medicare and Medicaid Services began to deny reimbursement for HAIs. Now that hospitals are no longer being reimbursed for selected HAIs, the loss of revenue is greater than ever before. The challenge to nurses and practitioners is to steer acute health care facilities to a course on which all measures that can prevent HAIs are identified and adopted, with a focus on eliminating the most costly infections, those caused by antibiotic-resistant bacteria.
Infections caused by cross-contamination with resistant bacteria can be eliminated by 3 methods: kill the bacteria before resistance develops, stop bacteria from communicating and acquiring resistance, and eliminate the pathway from one patient to another. The third method is particularly challenging due to the number of patients treated at health care facilities and the need to conserve and reuse resources and equipment between patients. Electrocardiography equipment is one example. Because electrocardiography equipment cannot be completely disinfected 100% of the time, it may be contributing to the growth of resistant bacteria. Reusable electrocardiography (ECG) wires, specifically the wire lead sets that connect the electrodes placed on a patient's chest to the trunk cable of a hardwired monitor or to a telemetry box, are a ubiquitous pathway for communication of HAIs caused by resistant organisms. ECG wires attached to even the least mobile patients can be found wrapped around endotracheal tubes, tracheostomy tubes, chest tubes, drains, urinary catheters, and so on, and the methods used to clean these reusable wires between patients is usually not effective enough to prevent cross-contamination of bacteria. A finding that reusable ECG wires carry and transport resistant bacteria after the wires are cleaned per hospital protocol was first reported in 2003 and again 5 years later in 2008. A multicenter study conducted in early 2009 also indicated that ECG wires were a potential source of HAI. A recent article in Cardiology News stated that antibiotic-resistant bacteria were found on 77% of ECG lead wires that were cultured after they were reprocessed and just before they were attached to new patients in the intensive care unit (ICU). The researcher, Dr. Paul R. Brookmeyer of the University of Wisconsin Hospital and Clinics, Madison was quoted as saying the wires are “‘an unappreciated reservoir’ of multidrug-resistant nosocomial pathogens.” In addition, the article concluded that “attachment of contaminated lead wires to a new patient can result in colonization and ultimately in invasive infection by multiresistant nosocomial microorganisms.”
ECG wires, identified as carriers of resistant strains of bacteria and an invasive infection risk, were thus linked directly to the root cause of cross-contamination infection in an article from the Division of Infectious Diseases at the University of Texas, Medical Branch in Galveston. The burn unit of that university hospital experienced “an outbreak of colonization and infection caused by vancomycin-resistant enterococci.” Five weeks after the apparent eradication, the outbreak reoccurred. The reemergence of the infection was traced to one ECG lead wire. In addition to this account, Wisconsin hospital epidemiologists attributed an outbreak of Serratia marcescens infection to insufficiently decontaminated ECG leads. Unfortunately, these reports show that merely following a cleaning protocol for ECG wires is not sufficient to eliminate the risk of cross-contamination, even a cleaning protocol as rigorous as that expected from a burn unit attempting to eradicate an outbreak of vancomycin-resistant enterococci. Because of the nature of bacteria and the methods of development and transfer of antibiotic resistance, cleaning methods with bactericidal agents may be compounding the problem and contributing to the development of drug-resistant organisms.
Disposable electrocardiography leads might eliminate the risk of infection through these pathways. Adoption of disposable electrocardiography leads as an adjunct to an overall infection control program can decrease infection rates in acute health care facilities. However, there is a significant cost associated with the adoption of single-patient use disposable EKG Leads, especially in high patient “turnover” areas such as the OR, Procedural Areas, and ICU. What is needed is an alternate method for disinfecting or reusing lead wire cables that can be easily and inexpensively accomplished while still providing protection from cross-contamination between uses.